This position will play a crucial role in the startup of insulin manufacturing. The Project Manager is responsible for overseeing the planning, execution, and completion of projects in support of insulin programs. Strong knowledge of project management methodologies, biologics processes and regulatory pathways is required to be successful in this role.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead end-to end project management, including initiation, planning, execution, monitoring and project closure.
- Define scope, objectives, deliverables, and timelines in collaboration with stakeholders.
- Develop comprehensive project plans and resource loaded schedules to ensure on-time implementation.
- Create project dashboards for the monitoring of progress, identifying risk and implementing mitigation strategies.
- Build strong relationships with stakeholders and effectively communicate project updates and challenges.
- Manage project-related meetings, document meeting minutes, decisions, and action items.
- Prepare project status reports and present to site and above-site leadership.
- Conduct thorough project reviews to identify lessons learned and areas for continuous improvement.
- Promote a culture of continuous improvement throughout the site, fostering innovation and best practices.
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Bachelor’s degree and 7+ years of project management experience. PMP certification preferred.
- Must be versed in Project Management tools and must have knowledge of related disciplines.
- Experience working in cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
- Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Start-up experience preferred.
- Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.
- Advanced computer skills with working knowledge of MS Project, Office, Word, Excel, PowerPoint, etc.
- Excellent oral and written communication skills, including presentations.